FDA.reportPublic FDA data

Phenobarbital

Product NDC
16571-675
11-digit product format
165710675
Labeler code
16571
Product ID
16571-675_a84eee2c-e36f-478c-8793-b153799ea38b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
LIQUID
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-09-01
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL20 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui702519

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-675-16Phenobarbital473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-675PHENOBARBITAL LIQUID [RISING PHARMA HOLDINGS, INC.]1Current NDC, Legacy NDC, 1 package rows20200916_fe874f8a-4b56-4d2b-abf5-8742e2633a3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSNd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519phenobarbital 4 MG/ML Oral SolutionSCDd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519phenobarbital 20 MG per 5 ML Oral SolutionSYd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSYd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519phenobarbital 60 MG per 15 ML Oral SolutionSYd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSNee1fe3ac-7a2e-4133-90a2-1d8dc0552e74100
702519phenobarbital 4 MG/ML Oral SolutionSCDee1fe3ac-7a2e-4133-90a2-1d8dc0552e74100
702519phenobarbital 20 MG per 5 ML Oral SolutionSYee1fe3ac-7a2e-4133-90a2-1d8dc0552e74100
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSYee1fe3ac-7a2e-4133-90a2-1d8dc0552e74100
702519phenobarbital 60 MG per 15 ML Oral SolutionSYee1fe3ac-7a2e-4133-90a2-1d8dc0552e74100
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSNfe874f8a-4b56-4d2b-abf5-8742e2633a3b1
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSNac26cd10-8f66-4254-957c-87a909b576f81
702519phenobarbital 4 MG/ML Oral SolutionSCDac26cd10-8f66-4254-957c-87a909b576f81
702519phenobarbital 4 MG/ML Oral SolutionSCDfe874f8a-4b56-4d2b-abf5-8742e2633a3b1
702519phenobarbital 20 MG per 5 ML Oral SolutionSYfe874f8a-4b56-4d2b-abf5-8742e2633a3b1
702519phenobarbital 20 MG per 5 ML Oral SolutionSYac26cd10-8f66-4254-957c-87a909b576f81
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSYfe874f8a-4b56-4d2b-abf5-8742e2633a3b1
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSYac26cd10-8f66-4254-957c-87a909b576f81
702519phenobarbital 60 MG per 15 ML Oral SolutionSYfe874f8a-4b56-4d2b-abf5-8742e2633a3b1
702519phenobarbital 60 MG per 15 ML Oral SolutionSYac26cd10-8f66-4254-957c-87a909b576f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-675-1616571067516473 mL in 1 BOTTLE (16571-675-16) 473 ml2020-09-010000-00-00NoNoCurrent